510(k) Report

510(k) · Cleared

Cleared

Cut-Tec or Wells Lamont Polyester/Wire Cut-Resistant Glove Liner Wells-Tec, Scepter

K944763510(k) TraditionalCleared Apr 10, 1995195-day reviewClass I21 CFR 878.4040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wells Lamont Corp. · LYU Accessory, Surgical Apparel

Cleared on Apr 10, 1995 after a 195-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Apr 10, 1995
Review
195 days
Class
Class I
Product code
LYU
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K944763Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LYU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LYU devices

LYU Accessory, Surgical Apparel: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYU

FDA has decided no LYU device since 2007.

Median 510(k) review, days · LYU

Too few LYU 510(k)s in any year since 2007 to give a median.

Recalls per year · LYU

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYU

5in 2025

2007: 12008: 42011: 52012: 32013: 132014: 72015: 12016: 492017: 112018: 12019: 12020: 92021: 22022: 42024: 32025: 5
2007high 49 (2016) · low 0 (2009)2025

MAUDE reports naming product code LYU, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—04
20090—00
20100—00
20110—05
20120—03
20130—013
20140—07
20150—01
20160—049
20170—111
20180—01
20190—01
20200—09
20210—02
20220—04
20230—00
20240—03
20250—05
20260—0—

More from Wells Lamont Corp.

4 FDA decisions under this applicant name. See the company

  • K940274Nylon Liner GlovesWells Lamont Corp. · 1994
  • K925937Wells Lamont Handages/Med Wrap DressingsWells Lamont Corp. · 1993
  • K922407Wells Lamont Cut Resistant Surgical Glove LinersWells Lamont Corp. · 1993

Recent decisions in LYU

The LYU category page

  • K011755Stryker T4 Hytrel (R) TogasStryker Corp. · 2001
  • K965237Nurses Bouffant CapCopioumed Intl., Inc. · 1997
  • K970988Far-East Bouffant CapsFar East Science & Technology Development Co., Ltd. · 1997
  • K964364Disposable ApronInstrument Makar, Inc. · 1997
  • K961791Depuy Disposable Filter/HoodDepuy, Inc. · 1996

https://510kreport.com/device/K944763 · printed Nov 4, 2026

Cite this page

510(k) Report. “K944763: Cut-Tec or Wells Lamont Polyester/Wire Cut-Resistant Glove Liner Wells-Tec, Scepter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944763

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026